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Prevention Research

Factors Associated With Condom Failure in a Longitudinal Cohort of Men Who Have Sex With Men and Transgender Women in Abuja and Lagos, Nigeria

Hamill, Matthew M. MBChB, PhDa; Hu, Fengming MSb,c; Kokogho, Afoke MBBS, MPHb,d; Shoyemi, Elizabeth MSe; Ekeh, Charles MBBS, MPHe; Charurat, Manhattan E. PhD, MHSf; Robb, Merlin L. MDc; Adebajo, Sylvia MD, PhDg; Baral, Stefan D. MD, MPH, MBAh; Nowak, Rebecca G. PhDf; Crowell, Trevor A. MD, PhDa,b,c; for the TRUST/RV368 Study Group

Author Information
JAIDS Journal of Acquired Immune Deficiency Syndromes: March 1, 2021 - Volume 86 - Issue 3 - p 329-338
doi: 10.1097/QAI.0000000000002559

Abstract

INTRODUCTION

Despite declining global HIV incidence over the past decade, many countries are not on target to reach World Health Organization goals of reduction in incidence and mortality by 2020 and 2030.1 Furthermore, advances in HIV treatment and prevention efforts are not spread equally across all populations; men who have sex with men (MSM)2,3 and transgender women (TGW)4 have not experienced the same magnitude of declines in HIV incidence as has been observed in other groups. Many biological, behavioral, and systems-based factors collectively determine individual risk of HIV; however, receptive anal sex with serodiscordant and viremic partners is one of the most efficient modes of transmission5 and is more commonly practiced by MSM and TGW than other groups. For those who engage in anal sex, the latex condom is one of the cornerstones of HIV prevention. However, for physiological and mechanical reasons, condom breakage or slippage is more common during anal than vaginal sex.6,7 Application of condom-compatible lubricant (CCL) minimizes condom failure,8 but other types of lubricants may actually promote failure. For example, petroleum-based lubricants may degrade latex condoms and, in MSM, are associated with approximately 6 times greater likelihood of breakage as compared with water-based lubricants.9

In areas of the world with the highest burden of HIV and the lowest access to prevention tools like preexposure prophylaxis, MSM, TGW, and those with nonbinary or other gender identities face many barriers to accessing appropriate and sensitive health care that includes the provision of safer sex advice, condoms, and CCL. Indeed, CCL did not appear in HIV prevention efforts for MSM sponsored by the US President's Emergency Plan for AIDS Relief until 2011, so provision by clinics and nongovernmental organizations was historically limited.10,11

Nigeria has a substantial HIV burden, with its residents accounting for approximately 9% of the global population living with HIV in 2014,12 despite making up only approximately 2.5% of the total global population.13,14 In 2019, the reported HIV prevalence in Nigerian males aged 15–49 years was 0.9%,15 a fall from 1.3% in 2018. In contrast, in 2018, the HIV prevalence in Nigerian MSM was 23%.16 Our group has previously reported HIV prevalence as high as 44%–66% in Nigerian MSM and TGW accessing trusted community health centers.17 Prior studies of Nigerian MSM have demonstrated that 32%–51% reported consistent condom use with noncommercial male sexual partners during the previous 6 months.18 Other studies have demonstrated consistent condom use among less than 40% of Nigerian university students.19 Even when condoms are widely available, this does not consistently translate into decreased infections for a range of reasons, including condom failure through breakage and slippage.20–22

Prior studies evaluating factors associated with condom failures in African settings were comparatively small23 and were often conducted in the context of female sex work24 that is associated with power imbalances, deliberate condom damage by male clients,25 and not exclusively focused on anal sex.23 Others are almost a decade old.26 Studies focusing on condom failure in African MSM likewise tend to be small, cross sectional, focused on sex workers and their clients, and do not include TGW.27–31 To understand contemporary factors associated with condom failure in Nigerian MSM, TGW, and other gender identities required a large sample engaged in longitudinal follow-up. From September 2013 to September 2019, we examined factors associated with condom failure during anal sex with men among MSM and TGW in Abuja and Lagos, Nigeria.

METHODS

Study Population

TRUST/RV368 was a prospective cohort study involving MSM, TGW, and other sexual and gender minorities who were assigned male sex at birth in Abuja and Lagos, Nigeria, as previously described.17 The study used respondent-driven sampling (RDS) for recruitment. Briefly, several first-wave, enrolled participants representing a variety of sociodemographic backgrounds were each provided with 3 referral coupons to distribute to other potential participants in their social networks. Each successfully enrolled referral was provided with another 3 coupons to distribute. RDS is an efficient means of accessing participant populations that are marginalized by general health care and therefore may be missed by other recruitment methods.32,33 Study eligibility required participants to be adult (≥16 years in Abuja; ≥18 years in Lagos), have been assigned male sex at birth, report anal sex with a male partner in the 12 months before enrollment, and present with a valid RDS referral coupon.

The study took place at preexisting community health centers that were run by local nongovernmental organizations, supported by President's Emergency Plan for AIDS Relief, and provided comprehensive HIV treatment and prevention services tailored to MSM, TGW, and other sexual and gender minorities. Local standards of care included the syndromic management of sexually transmitted infections (STIs) and quarterly HIV testing. TRUST/RV368 worked in parallel with these services to provide additional enhanced counseling, free condoms/lubricants, peer support, and advanced STI diagnostics. Key opinion leaders within the community and peer navigators encouraged continued study engagement and attendance at study visits every 3 months.34 Enrollment evaluations took place over the first 2 visits, approximately 2 weeks apart. Upon enrollment, all participants underwent screening for HIV and other STIs. HIV testing used a parallel algorithm of point-of-care testing with a third tie-breaker test as required. The tests were Determine (Alere, Waltham, MA), Uni-gold (Trinity Biotech, Wicklow, Ireland), and STAT-PAK (Chembio, NY) performed per package inserts. Pre- and posttest counseling accompanied each episode of STI and HIV screening and was provided by counselors trained in MSM and TGW health-related issues. The counseling was participant specific and included education about, and provision of, condoms and water-based lubricants. Reimbursement was provided for study visits (Naira 2000–3400, equal to about US$6–11, depending on visit) and for each referral resulting in an enrollment (Naira 1500, equal to about US$5).

All participants provided written informed consent before enrollment and any study procedures. The study was conducted in accordance with the ethical standards of the responsible committee on human experimentation and with the Helsinki declaration, 1975 as revised in 2000. The study protocol was approved by Health Research Ethics Committees or Institutional Review Boards at the Nigerian Federal Capital Territory and Nigerian Ministry of Defense, Abuja, Nigeria; University of Maryland, Baltimore, MD; Johns Hopkins University, Baltimore, MD; and Walter Reed Army Institute of Research, Silver Spring, MD.

Sexual Behaviors and Condom Failures

Demographic details, sexual and social behaviors, self-reported transactional sex, defined as any exchange of sex for goods or money, and condom and lubricant use were assessed by structured interview at each visit by trained research staff. The structured interview varied by visit and included questions about condom failure at enrollment as well as 3, 9, and 15 months after enrollment. Participants were asked, “In the last month approximately how many male partners did you have anal sex with?” Those who reported one or more partners for anal sex were subsequently asked about condom failure in the past month, defined as “a time when a condom slipped off or broke.”

Statistical Analysis

Comparisons between participants who did or did not experience condom failure were the focus of these analyses. If the answer to the question about condom failure was missing, the participant refused to answer, or the participant responded “don't know,” that participant visit was excluded from the analyses. Because condom use is required to experience condom failure, only visits at which the participant reported condom use during anal sex were included in these analyses.

Among participants who reported condom use during anal sex, comparisons between those who did or did not experience condom failure were made using Pearson χ2 test, the exact χ2 test, or Wilcoxon test, as appropriate. Medians and interquartile ranges were reported for continuous variables. Prespecified factors potentially associated with condom failure, selected a priori based on review of the literature, were explored using unadjusted and adjusted Poisson regression models with generalized estimating equations and robust error variance to estimate relative risks (RRs) and 95% confidence intervals (CIs).35 The models included time-updated values for age, HIV status, lubricant used most during anal sex with men, transactional sex with men, number of casual and main sexual partners, and anal sex position. All other variables were static based on assessment at enrollment.

To explore effect modification by gender identity, Poisson regression models with generalized estimating equations and robust variance estimators were repeated in subgroup analyses limited to (1) cisgender men, (2) TGW, and (3) nonbinary and other gender identities. Because of smaller sample sizes for the latter 2 subgroups, some categorical independent variables were collapsed or dichotomized to facilitate multivariable model convergence.

A 2-sided type-1 error of 5% was considered statistically significant for all analyses. Analyses were performed using SAS version 9.4 (SAS Institute Inc., Cary, NC).

RESULTS

Study Population

From September 2013 to September 2019, 2737 participants were enrolled in TRUST/RV368, including 2221 (81.1%) who reported condom use during anal sex with a male partner and answered the question about condom failure in the month before any study visit. This included 1771 cisgender men (79.7%), 233 TGW (10.0%), and 198 participants (8.9%) who reported nonbinary/other gender identity. Of the participants included in these analyses, 1962 reported condom use during anal sex at the enrollment visit, and an additional 259 reported condom use only at later visits. Those who contributed data only at later study visits differed from those who reported condom use at entry in most domains evaluated (see Table 1, Supplemental Digital Content, http://links.lww.com/QAI/B567) except for condom failure in the previous month (12.7% vs. 13.9%; P =0.622).

At the first visit at which condom use during anal sex was reported, 305 participants (13.7%) reported condom failure in the previous month. Participants who reported condom failure were more likely to be educated at a secondary level or above, be single, be Christian, report nearly daily internet use, and be living with HIV or have unknown HIV status (Table 1). They were less likely to be married to a woman and report lubricant use. Participants with condom failure in the previous month also reported a greater number of casual male sexual partners than those who did not experience condom failure [median 4 (interquartile range 2–10) vs. 3 (1–6); P < 0.0001].

TABLE 1. - Characteristics of TRUST/RV368 Participants Who Reported Anal Sex With Male Partners in the Preceding Month, Stratified by Self-Reported Condom Failure in the Preceding Month
Characteristic Category Total (n = 2221) No Condom Failure (n = 1916) Condom Failure (n = 305) P
Age ≤21 yrs 747 (33.6) 654 (34.1) 93 (30.5) 0.305
22–30 yrs 1257 (56.6) 1072 (55.9) 185 (60.7)
>30 yrs 217 (9.8) 190 (9.9) 27 (8.9)
Gender identity Cisgender man 1771 (79.7) 1529 (79.8) 242 (79.3) 0.209
Transgender woman 233 (10.5) 195 (10.2) 38 (12.5)
Nonbinary/other 198 (8.9) 173 (9.0) 25 (8.2)
Missing/unknown 19 (0.9) 19 (1.0) 0 (0)
Education Junior secondary or less 288 (13.0) 272 (14.2) 16 (5.2) <0.001
Senior secondary 1183 (53.3) 1009 (52.7) 174 (57.0)
Higher than senior secondary 732 (33.0) 619 (32.3) 113 (37.0)
Missing/unknown 18 (0.8) 16 (0.8) 2 (0.7)
Marital status Single/never married 2013 (90.6) 1725 (90.0) 288 (94.4) 0.038
Married/living with a woman 116 (5.2) 111 (5.8) 5 (1.6)
Living with a man 29 (1.3) 24 (1.3) 5 (1.6)
Divorced/other 49 (2.2) 43 (2.2) 6 (2.0)
Missing/unknown 14 (0.6) 13 (0.7) 1 (0.3)
Religion Christian 1601 (72.1) 1354 (70.7) 247 (81.0) 0.008*
Muslim 596 (26.8) 540 (28.2) 56 (18.4)
None/other 12 (0.5) 10 (0.5) 2 (0.7)
Missing/unknown 12 (0.5) 12 (0.6) 0 (0)
Internet use Never 430 (19.4) 403 (21.0) 27 (8.9) <0.001
≤3 times per wk 454 (20.4) 397 (20.7) 57 (18.7)
Almost every day 1311 (59.0) 1090 (56.9) 221 (72.5)
Missing/unknown 26 (1.2) 26 (1.4) 0 (0)
HIV status At risk 1322 (59.5) 1162 (60.6) 160 (52.5) <0.001
Living with HIV 670 (30.2) 574 (30.0) 96 (31.5)
Unknown 229 (10.3) 180 (9.4) 49 (16.1)
Lubricant used most Water based 978 (44.0) 824 (43.0) 154 (50.5) 0.002
Other lubricants 445 (20.0) 379 (19.8) 66 (21.6)
No lubricant use 396 (17.8) 364 (19.0) 32 (10.5)
Missing/unknown 402 (18.1) 349 (18.2) 53 (17.4)
Transactional sex No 944 (42.5) 820 (42.8) 124 (40.7) 0.458
Yes 1241 (55.9) 1063 (55.5) 178 (58.4)
Missing/unknown 36 (1.6) 33 (1.7) 3 (1.0)
Casual sexual partners None 345 (15.5) 316 (16.5) 29 (9.5) <0.001
1 254 (11.4) 229 (12.0) 25 (8.2)
2–4 784 (35.3) 681 (35.5) 103 (33.8)
5 or more 757 (34.1) 617 (32.2) 140 (45.9)
Missing/unknown 81 (3.6) 73 (3.8) 8 (2.6)
Main sexual partners None 382 (17.2) 327 (17.1) 55 (18.0) 0.021
1 922 (41.5) 814 (42.5) 108 (35.4)
2–4 734 (33.0) 611 (31.9) 123 (40.3)
5 or more 174 (7.8) 155 (8.1) 19 (6.2)
Missing/unknown 9 (0.4) 9 (0.5) 0 (0)
Anal sex position Only insertive 593 (26.7) 513 (26.8) 80 (26.2) 0.700
Only receptive 495 (22.3) 431 (22.5) 64 (21.0)
Both insertive and receptive 1090 (49.1) 933 (48.7) 157 (51.5)
Missing/unknown 43 (1.9) 39 (2.0) 4 (1.3)
Demographic and other characteristics are shown for all TRUST/RV368 participants who reported anal sex with one or more male partners. Data came from the first visit satisfying the following criteria (1) the participant reported anal sex in the preceding month and (2) the participant answered the structured interview question about condom breakage or slippage in the preceding month. All responses are reported as n (%).
Statistically significant P-values (P < 0.05) are shown in bold.
*P-values were calculated using Pearson χ2 test or exact χ2 test.

Factors Associated With Condom Failure

Table 2 describes unadjusted and adjusted RRs for associations of various characteristics with condom failure within the previous month. After adjusting for other factors, increased risk of condom failure was observed after the enrollment visit, with increased Internet use, with 2 or more causal sexual partners, and with 2–4 main sexual partners. Participants who did not use lubricant had the lowest risk of condom failure. In addition, being married to or living with a woman and identifying as a Muslim were associated with decreased risk of condom failure.

TABLE 2. - Factors Associated With Condom Failure During Anal Sex With a Man in the Preceding Month
Characteristic Category RR P aRR P
Visit Enrollment Reference
3 mo 1.11 (0.92–1.34) 0.281 1.33 (1.08–1.64) 0.007
9 mo 1.17 (0.94–1.45) 0.156 1.38 (1.09–1.75) 0.007
15 mo 1.11 (0.88–1.40) 0.364 1.34 (1.04–1.73) 0.024
Age ≤21 yrs Reference
22–30 yrs 1.08 (0.90–1.30) 0.418 1.01 (0.83–1.22) 0.953
>30 yrs 0.93 (0.69–1.25) 0.614 1.02 (0.74–1.41) 0.892
Gender identity Cisgender man Reference
Transgender woman 1.29 (1.02–1.63) 0.034 1.15 (0.90–1.47) 0.256
Nonbinary/other 1.05 (0.78–1.40) 0.766 0.94 (0.71–1.25) 0.695
Missing/unknown 0.43 (0.14–1.39) 0.159 0.42 (0.13–1.34) 0.142
Education Junior secondary or less Reference
Senior secondary 1.79 (1.21–2.66) 0.004 1.19 (0.79–1.78) 0.408
Higher than senior secondary 1.87 (1.25–2.79) 0.002 1.19 (0.78–1.82) 0.423
Missing/unknown 1.76 (0.59–5.26) 0.314 1.63 (0.66–4.02) 0.289
Marital status Single/never married Reference
Married/living with a woman 0.42 (0.25–0.73) 0.002 0.53 (0.31–0.92) 0.023
Living with a man 1.27 (0.73–2.21) 0.393 0.97 (0.54–1.72) 0.906
Divorced/other 0.83 (0.51–1.34) 0.444 0.78 (0.48–1.29) 0.334
Missing/unknown 0.80 (0.35–1.82) 0.593 1.45 (0.69–3.05) 0.331
Religion Christian* Reference
Muslim 0.60 (0.47–0.75) <0.001 0.71 (0.55–0.90) 0.006
None/other 0.60 (0.16–2.26) 0.447 0.56 (0.14–2.18) 0.403
Internet use Never* Reference
≤3 times per week 1.84 (1.31–2.58) <0.001 1.35 (0.96–1.91) 0.088
Almost every day 2.13 (1.59–2.87) <0.001 1.54 (1.12–2.11) 0.007
HIV status At risk Reference
Living with HIV 1.33 (1.12–1.57) 0.001 1.12 (0.93–1.35) 0.224
Missing/unknown 1.70 (1.29–2.25) <0.001 1.27 (0.94–1.71) 0.118
Lubricant used most Water based Reference
Other lubricants 1.04 (0.85–1.27) 0.712 1.06 (0.87–1.30) 0.566
No lubricant use 0.56 (0.41–0.75) <0.001 0.71 (0.52–0.97) 0.033
Missing/unknown 0.80 (0.62–1.02) 0.069 0.95 (0.73–1.23) 0.673
Transactional sex No Reference
Yes 1.22 (1.05–1.43) 0.010 1.14 (0.97–1.35) 0.114
Missing/unknown 0.78 (0.31–1.92) 0.583 0.97 (0.38–2.46) 0.944
Casual sexual partners None Reference
1 1.25 (0.93–1.68) 0.142 1.23 (0.92–1.65) 0.171
2–4 1.72 (1.34–2.20) <0.001 1.74 (1.35–2.26) <0.001
5 or more 2.07 (1.61–2.66) <0.001 2.15 (1.62–2.85) <0.001
Missing/unknown 1.12 (0.59–2.11) 0.728 1.55 (0.79–3.03) 0.203
Main sexual partners None* Reference
1 0.93 (0.75–1.15) 0.505 1.04 (0.84–1.29) 0.704
2–4 1.17 (0.94–1.46) 0.161 1.33 (1.06–1.66) 0.012
Five or more 0.84 (0.54–1.30) 0.435 1.02 (0.66–1.58) 0.943
Anal sex position Only insertive Reference
Only receptive 1.07 (0.86–1.35) 0.536 0.95 (0.74–1.22) 0.675
Both insertive and receptive 1.17 (0.96–1.41) 0.114 1.00 (0.82–1.22) 0.998
Missing/unknown 0.81 (0.38–1.70) 0.576 1.03 (0.45–2.33) 0.945
Robust Poisson regression with generalized estimating equations was used to estimate risk ratios and 95% confidence intervals for prespecified factors potentially associated with condom failure, defined as self-reported breakage or slippage in the last month among participants who reported anal sex with male partners in that same time frame. Data from all available outcome assessments were included in statistical models, including the enrollment visit and follow-up visits at 3, 9, and 15 months. All listed variables were included in the adjusted models.
Statistically significant risk ratios (P < 0.05) are shown in bold.
*Participants with missing/unknown data were included in the reference category.

Subgroup Analyses by Gender Identity

These analyses included 1771 cisgender MSM who reported condom use during anal sex in the preceding month at 3053 visits and condom failure in the preceding month at 442 visits (14.5%); 233 TGW who reported condom use during anal sex at 422 visits and condom failure at 80 visits (19.0%); and 198 participants with nonbinary or other gender identity who reported condom use during anal sex at 358 visits and condom failure at 55 visits (15.4%). Table 3 describes the subgroup analyses for factors associated with condom failure among each of these gender subgroups.

TABLE 3. - Factors Associated With Condom Failure During Anal Sex With a Man in the Preceding Month, Subgroup Analyses by Gender Identity
Characteristic Category Cisgender Men Transgender Women Nonbinary/Other
RR aRR RR aRR RR aRR
Visit Enrollment Reference
3 mo 1.11 (0.92–1.34) 1.19 (0.94–1.51) 1.11 (0.92–1.34) 2.03 (1.12–3.67) 1.11 (0.92–1.34) 2.00 (0.92–4.33)
9 mo 1.17 (0.94–1.45) 1.25 (0.96–1.64) 1.17 (0.94–1.45) 2.47 (1.26–4.83) 1.17 (0.94–1.45) 1.69 (0.78–3.69)
15 mo 1.11 (0.88–1.40) 1.21 (0.91–1.61) 1.11 (0.88–1.40) 1.85 (0.90–3.81) 1.11 (0.88–1.40) 2.39 (0.99–5.76)
Age ≤21 yrs Reference
22–30 yrs 1.16 (0.93–1.44) 1.06 (0.84–1.34) 0.75 (0.49–1.17) 0.74 (0.49–1.11) 1.27 (0.65–2.49) 1.09 (0.51–2.29)
>30 yrs 0.85 (0.60–1.20) 0.93 (0.63–1.37) 0.93 (0.39–2.20) 0.74 (0.35–1.53) 2.14 (0.96–4.75) 2.10 (0.79–5.58)
Education Junior secondary or less Reference * * * *
Senior secondary 1.99 (1.25–3.19) 1.29 (0.79–2.12) 2.70 (0.88–8.27) 1.80 (0.57–5.70) 0.60 (0.25–1.41) 0.75 (0.29–1.91)
Higher than senior secondary 2.17 (1.35–3.49) 1.34 (0.80–2.24) 2.55 (0.80–8.10) 1.75 (0.54–5.64) 0.54 (0.21–1.36) 0.52 (0.18–1.52)
Missing/unknown 3.48 (1.07–11.36) 2.12 (0.89–5.02)
Marital status Single/never married Reference * *
Married/living with a woman 0.46 (0.26–0.81) 0.57 (0.33–0.99) 1.10 (0.56–2.15) 0.90 (0.45–1.78) 0.55 (0.08–3.88) 0.30 (0.03–3.02)
Living with a man 1.10 (0.57–2.12) 0.87 (0.43–1.75) 1.09 (0.20–5.92) 0.63 (0.07–6.03)
Divorced/other 0.69 (0.35–1.36) 0.72 (0.36–1.46) 0.84 (0.20–3.46) 0.79 (0.26–2.37)
Missing/unknown 1.87 (1.23–2.86) 1.89 (1.14–3.14)
Religion Christian* Reference
Muslim 0.58 (0.45–0.76) 0.69 (0.52–0.92) 0.55 (0.31–0.98) 0.67 (0.36–1.24) 0.81 (0.38–1.72) 0.68 (0.31–1.52)
None/other 0.60 (0.16–2.30) 0.57 (0.15–2.22)
Internet use Never* Reference
≤ 3 times per week 1.72 (1.18–2.52) 1.25 (0.84–1.86) 2.20 (0.77–6.27) 1.46 (0.53–4.05) 2.06 (0.64–6.66) 2.54 (0.88–7.35)
Almost every day 2.07 (1.49–2.87) 1.45 (1.02–2.07) 3.03 (1.15–7.99) 1.80 (0.68–4.82) 1.60 (0.54–4.75) 2.21 (0.68–7.21)
HIV status At risk Reference
Living with HIV 1.26 (1.05–1.53) 1.08 (0.88–1.33) 1.47 (0.87–2.51) 1.04 (0.58–1.86) 1.49 (0.80–2.78) 1.14 (0.58–2.24)
Missing/unknown 1.53 (1.09–2.15) 1.16 (0.81–1.65) 2.02 (1.05–3.86) 1.70 (0.80–3.61) 2.26 (0.91–5.59) 1.28 (0.45–3.65)
Lubricant used most Water based Reference
Other lubricants 1.04 (0.84–1.30) 1.07 (0.86–1.34) 1.11 (0.62–1.98) 1.08 (0.66–1.78) 0.95 (0.46–1.96) 0.88 (0.46–1.71)
No lubricant use 0.51 (0.36–0.73) 0.62 (0.43–0.89) 0.67 (0.32–1.41) 1.13 (0.53–2.43) 1.17 (0.53–2.57) 1.78 (0.76–4.17)
Missing/unknown 0.75 (0.56–1.00) 0.87 (0.64–1.18) 1.30 (0.77–2.21) 1.92 (1.08–3.39) 0.75 (0.32–1.74) 1.03 (0.39–2.68)
Transactional sex No Reference * *
Yes 1.13 (0.95–1.35) 1.08 (0.89–1.30) 1.55 (1.03–2.32) 1.42 (0.89–2.28) 1.41 (0.81–2.48) 1.23 (0.67–2.27)
Missing/unknown 0.67 (0.23–1.97) 0.90 (0.31–2.60) 3.30 (0.85–12.75) 7.94 (2.09–30.15)
Casual sexual partners None Reference
1 1.29 (0.93–1.77) 1.27 (0.92–1.76) 1.18 (0.42–3.31) 0.98 (0.38–2.56) 0.91 (0.33–2.52) 0.93 (0.29–3.03)
2–4 1.72 (1.30–2.28) 1.78 (1.33–2.38) 1.63 (0.81–3.29) 1.39 (0.67–2.90) 1.63 (0.70–3.79) 1.88 (0.84–4.22)
5 or more 1.93 (1.45–2.57) 1.96 (1.42–2.71) 2.18 (1.14–4.15) 2.30 (1.05–5.03) 2.69 (1.15–6.29) 3.56 (1.56–8.15)
Missing/unknown 0.82 (0.36–1.90) 1.06 (0.41–2.73) 1.29 (0.28–5.88) 0.91 (0.35–2.32) 3.21 (0.93–11.09) 3.05 (0.74–12.63)
Main sexual partners None Reference
1 1.03 (0.80–1.32) 1.15 (0.90–1.48) 0.50 (0.30–0.83) 0.59 (0.35–0.99) 1.30 (0.59–2.84) 1.65 (0.77–3.51)
2–4 1.22 (0.94–1.57) 1.43 (1.11–1.85) 0.77 (0.46–1.29) 0.88 (0.51–1.53) 1.58 (0.65–3.85) 2.03 (0.84–4.87)
5 or more 1.12 (0.72–1.75) 1.46 (0.92–2.31) 0.14 (0.02–1.08) 0.14 (0.02–1.05) § §
Anal sex position Only insertive Reference * *
Only receptive 1.03 (0.79–1.34) 1.02 (0.78–1.34) 0.86 (0.39–1.91) 0.81 (0.39–1.67) 1.35 (0.46–3.90) 1.36 (0.45–4.14)
Both insertive and receptive 1.10 (0.89–1.34) 0.98 (0.79–1.22) 1.11 (0.52–2.41) 1.00 (0.48–2.10) 1.83 (0.69–4.82) 1.63 (0.65–4.05)
Missing/unknown 0.66 (0.26–1.66) 1.07 (0.37–3.08) 3.77 (0.87–16.33) 3.06 (0.67–14.04)
Subgroup analyses were performed that restricted the study population to (1) cisgender men; (2) TGW; and (3) participants who reported nonbinary or other gender identity. Robust Poisson regression with generalized estimating equations was used to estimate risk ratios and 95% confidence intervals for prespecified factors potentially associated with condom failure, defined as self-reported breakage or slippage in the last month among participants who reported anal sex with male partners in that same time frame. Data from all available outcome assessments were included in statistical models, including the enrollment visit and follow-up visits at 3, 9, and 15 months. All listed variables were included in the adjusted models.
Statistically significant risk ratios (P < 0.05) are shown in bold. To enable convergence of statistical models, some categories were collapsed or dichotomized as noted.
*Participants with missing/unknown data were included in the reference category.
For the TGW subgroup, marital status was dichotomized with a reference group of “single/never married” compared against all other participants.
No participants in the TGW or nonbinary/other subgroups reported a religion of “none/other.”
§For the nonbinary/other subgroup, participants with 5 or more main sexual partners were included in the “2 to 4” category, effectively making this category “2 or more.”

In cisgender men, factors associated with condom failure were largely consistent with the primary analysis, including religion, Internet use, number of casual sexual partners, number of main sexual partners, and lubricant use. However, associations with visit number were not significant.

When restricted to TGW, condom failure was more common at visits 3 and 9 months after enrollment, whereas at 15 months, there was only a nonsignificant trend toward increased condom failure. Reporting greater than 5 casual partners was associated with greater risk, whereas having one main sex partner was associated with less risk of condom failure.

Among participants with nonbinary or other gender identities, there was no association with visit number except a nonsignificant trend toward greater risk of condom failure at the final visit. Increased risk of condom failure was observed only among participants with missing data on transactional sex with men and 5 or more casual partners.

Across all gender identity subgroups, increased number of casual sexual partners was associated with increased risk of condom failure. Lubricant usage was not consistently associated with condom failure; cisgender MSM who did not use lubricant had the lowest risk of condom failure, whereas this was associated with a nonsignificant trend toward greater risk of condom failure among TGW and nonbinary/other participants. TGW with missing data on lubricant use had significantly higher risk of condom failure than TGW who used water-based lubricants.

DISCUSSION

In this study, we found that more than 1 in 7 participants who had recently used condoms during anal sex with male partners experienced condom failure. Estimation of condom use and failure rates during anal sex across studies is beset with methodological problems because studies have used a wide variety of measurement methods, and the duration of recall has been inconsistent.36 Most prior studies were cross-sectional and the populations surveyed have differed in important characteristics, including age, gender, socioeconomic status, sexual orientation, and geographical location. A comprehensive review reported a range of condom breakage during anal sex of 0.5%–6.0% and slippage of 3.8%–5.0%.7 There are also differences by sexual positioning; one survey estimated total failure at 2.7% for receptive anal intercourse and 3.3% for insertive anal intercourse.37 An online survey of 9005 US MSM found a failure rate of 4.0% within the past 12 months.6 However, in a carefully conducted randomized crossover trial that employed daily coital diaries, the rate of clinical condom failure during anal sex was less than 1%.38 Despite the difficulties in directly comparing studies, condom failure was much more common in our study than would be expected based on prior studies. Stigma and marginalization of sexual and gender minority communities in Nigeria may lead to practices that encourage condom failure, such as sex in locations that are not conducive to proper condom use,39 rushed sex40 with casual partners that may complicate condom use and cause slippage through erection loss,41 and use of improvised lubricants.42 Further research is needed to fully explain the high rates of condom failure observed among the Nigerian MSM, TGW, and other gender minorities observed in our study.

Previous work by our group has demonstrated that engagement in care at a trusted community clinic increased the uptake of condoms and CCL.43 Availability and uptake are necessary but not sufficient for effective condom use, which also requires that a condom is used throughout the sex act without breakage or slippage. Disappointingly, the risk of condom failure did not decrease after enrollment into a study that included ongoing education about condom use and provision of free condoms with compatible lubricants. In fact, condom failure increased among TGW. This perhaps suggests a plateauing of the effect of safer sex messages or “message fatigue” in the majority of participants. It is also possible that increased uptake of condoms at later visits by new and inexperienced users contributed to the observation of increased condom failure particularly in TGW. In contrast, cisgender MSM did not experience increased condom failure over time. This observation may be explained by greater preenrollment use of condoms, greater condom use experience, and less likelihood of failure compared with new users. In addition, it could be explained by the cumulative effect of continuous education and condom provision by the study team at follow-up visits. However, prior studies have shown increased condom failure over time among MSM44,45 that may partially reflect underlying temporal changes in condom use for anal sex.44–46 In our study, however, the increase in condom failure over time was driven by the TGW participants. Future studies to address predictors of both condom use and failure in TGW are needed to better understand these phenomena.

In all groups, participants with greater numbers of casual sexual partners experienced more condom failure. For TGW, the risk of condom failure was reduced by having a single main partner. These complementary findings suggest that multiple sexual partnerships increase the risk of condom failure even if the per-act failure rate is low. However, other studies have demonstrated that greater experience with condom use is associated with less failure.47 Therefore, in our study, the context in which sex took place may have been an unmeasured confounder, especially if sex with multiple casual partners was rushed, furtive and without ready access to CCL.

Several other relationships emerged with condom failure in the group overall and specifically among cisgender men, including protective associations with Muslim religion and being married to or living with a woman. The association of Muslim religion with lower risk of condom failure is likely because of being circumcised.48 There were significant associations with higher Internet use. Interestingly, neither age, HIV status, nor sexual positioning were associated with condom failure in the multivariable model. Younger age has been previously associated with a number of adverse health outcomes in our cohort, including increased risk of HIV and other STIs, but this relationship does not appear to be mediated by condom failure.49 It is possible that perceptions of condom failure were influenced by sexual position, particularly for the receptive partner who would be unable to directly observe slippage and from whom breakage might be hidden. Such perceptions may have resulted in underreporting of condom failure. An unexpected finding was that no lubricant use was associated with less condom failure than water-based lubricant use in the whole group and in cisgender men. The mechanism underlying this finding is not clear; it is possible that those using water-based lubricants had more sex acts and were therefore more likely to report failure, that CCL was used too sparingly or that its use resulted in a false sense of security and promoted prolonged anal sex activity without reapplication. The individuals enrolled in TRUST/RV368 are part of a community with a very high and sustained incidence of HIV and a large burden of other STIs50,51 in whom proper and consistent condom use is critical.

Given these data, the acceptability and feasibility of other HIV/STI prevention measures in those with higher number of casual sexual partners should be explored. Data in Ugandan MSM suggest that there are barriers to condom use in addition to those around knowledge or access, these include societal norms,30 partner and relationship issues, and drug and alcohol consumption6,42 that were not addressed in this analysis. There are also factors related to self-efficacy, risk perception,27 stigma experience,28 pleasure,21 and condom fit52 that are important when taking a holistic approach to condom use, success, and failure. Suitable interventions tailored for individuals at the greatest risk of condom failure may reduce HIV/STI acquisition and onward transmission. Measures could include different-sized condoms, HIV pre- and postexposure prophylaxis, and other STI prevention strategies such as human papillomavirus and hepatitis B immunization.

The strengths of the study include large sample size, longitudinal design, partnership with trusted community organizations and the inclusion of TGW, and nonbinary and other gender identities that are historically underrepresented or conflated with MSM.53,54 Many of the differences seen in our study population were driven by cisgender MSM who contributed the majority of participants; whereas some similar trends were observed among TGW and participants with nonbinary or other gender identity, relatively lower sample sizes in these groups limited our power to observe statistically significant effects. Questions about condom failures were restricted to the month before each study visit partially to reduce the potential for recall bias, but this limited generalizability to more distant behaviors and condom failure patterns. The study did not capture the number of sex acts, so condom failure could not be calculated per anal sex act or compared with other studies that measured condom failure in that way. Another potential limitation was the inclusion of variables in statistical models that could have independent effects while simultaneously acting as mediators of other variables. The aims of these analyses were exploratory, not hypothesis driven, and focused on proximate cause mediators because these might generate future hypotheses resulting in interventions.

CONCLUSIONS

The data presented argue that provision of condoms, CCL, and education to sexual and gender minority population in friendly settings are insufficient measures to reduce condom failure to comparable levels seen in other studies. Differences exist between MSM, TGW, and nonbinary or other gender identities that require further study to inform differentiated care delivery and the development of specific interventions to decrease condom failure. Novel ways of planning health services are required to reduce the risk of HIV and other STIs by increasing condom use and to expand the repertoire of prevention methods to those unable to successfully navigate condoms. A shift from a solely disease-focused paradigm to a more nuanced one embracing pleasure, comfort, fit,55 partner attitudes, and motivation56,57 may be necessary to better advocate consistent condom use and reduce transmission of HIV and other STIs.

ACKNOWLEDGMENTS

The TRUST/RV368 Study Group includes Principal Investigators: M.E.C. (IHV, University of Maryland, Baltimore, MD), Julie Ake (MHRP, Walter Reed Army Institute of Research, Silver Spring, MD); Co-Investigators: Aka Abayomi, S.A., S.D.B., T.A.C., Charlotte Gaydos, A.K., Jennifer Malia, Olumide Makanjuola, Nelson Michael, Nicaise Ndembi, R.G.N., Oluwasolape Olawore, Zahra Parker, Sheila Peel, Habib Ramadhani, M.L.R., Cristina Rodriguez-Hart, Eric Sanders-Buell, E.S., Sodsai Tovanabutra, Sandhya Vasan; Institutions: Institute of Human Virology at the University of Maryland School of Medicine (IHV-UMB), Johns Hopkins Bloomberg School of Public Health (JHSPH), Johns Hopkins University School of Medicine (JHUSOM), U.S. Military HIV Research Program (MHRP), Walter Reed Army Institute of Research (WRAIR), Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF), Henry M. Jackson Foundation Medical Research International (HJFMRI), Institute of Human Virology Nigeria (IHVN), International Centre for Advocacy for the Right to Health (ICARH), The Initiative for Equal Rights (TIERS), Population Council Nigeria.

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Keywords:

gender; key and vulnerable populations; men who have sex with men; risk factors; transgender people; condoms; Nigeria

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